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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01546207
Other study ID # GCO 12-0045
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date August 2013

Study information

Verified date December 2019
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.


Description:

Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Age 18 to 90 years.

- History of coronary artery disease.

- Presence of, or planned for, an ICD prior to discharge.

- Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.

Exclusion Criteria:

- Ventricular arrhythmia not thought to be due to CAD.

- Unstable angina

- CVA within 30 days.

- Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography

- Pregnancy

- Any condition resulting in an absolute contraindication to anticoagulation

- Inability to follow-up at ICD clinic.

- Inability to give informed consent.

- Non-inducible for sustained monomorphic ventricular tachycardia.

- Prior substrate guided ablation.

- Definite need for epicardial ablation, as determined by the primary operator.

Study Design


Intervention

Procedure:
catheter-based ablation
specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia

Locations

Country Name City State
Brazil Hospital Regional Sao Jose Santa Catarina
Canada Southlake Regional Health Center Newmarket Ontario
Czechia Homolka Hospital Prague
Italy San Raffaele Hospital Milan
United States University of Alabama - Birmingham Birmingham Alabama
United States Beth Israel-Deaconess Medical Center Boston Massachusetts
United States Brigham & Women's Hospital Boston Massachusetts
United States Loyola University Maywood Illinois
United States Icahn School of Medicine at Mount Sinai New York New York
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Vivek Reddy Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Czechia,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Catheter Ablation The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia at time of catheter ablation procedure (intraoperative)
Secondary ICD Interrogation Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline. baseline and 6 months follow-up
Secondary Procedural Safety 2) Procedural safety as defined by the number of complication within 1week associated with the procedure. 1 week post-op
Secondary Signal-Average ECG Relationship between change in pre/post saECG and success of the step-wise ablation strategy baseline and post-op day one after procedure
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